Randomized, controlled trial of recombinant human interleukin-11 in patients with active Crohn's disease.

Abstract

BACKGROUND:

Interleukin-11 is a mesenchymally derived cytokine with pleiotropic activities. A pilot study suggested therapeutic benefit of recombinant human interleukin-11 (rhIL-11) in patients with Crohn's disease.

AIM:

To determine the safety and preliminary estimate of efficacy of rhIL-11 in treating active Crohn's disease.

METHODS:

Patients with mild to moderately active Crohn's disease, defined as a Crohn's disease activity index (CDAI) > or = 220 and < or = 450, were enrolled in a multicentre trial. Stable doses of 5-aminosalicylates, antibiotics, 6-mercaptopurine or azathioprine were permitted with appropriate wash-in periods. Oral, intravenous or rectally administered corticosteroids were not allowed. Patients were randomized to 6 weeks of subcutaneous injection with rhIL-11 15 microg/kg or placebo weekly, or rhIL-11 7.5 microg/kg or placebo twice weekly. The primary end-point was per cent change in CDAI at week 6; the major secondary end-point was the proportion of patients in remission, defined as a 100 point decrease in CDAI and absolute CDAI < or = 150.

RESULTS:

Baseline characteristics were similar among the 148 evaluated patients (49 placebo, 49 rhIL-11 15 microg/kg once weekly, 50 rhIL-11 7.5 microg/kg twice weekly). Treatment was well-tolerated, with mild injection site reactions occurring more frequently among patients treated with rhIL-11. Headache, oedema, and increased platelet count occurred significantly more often in the rhIL-11 7.5 microg/kg twice weekly group, but not the 15 microg/kg once weekly group. There was a trend toward decreased mean per cent change in CDAI in the rhIL-11 15 micro/kg once weekly group vs. placebo (-31.5% vs. -18.5%, 95% confidence interval for the difference -27.9-1.6%). A significantly greater proportion of patients receiving rhIL-11 15 microg/kg once weekly achieved remission compared to placebo (36.7% vs. 16.3%, 95% confidence interval for the difference 3.4-37.4%; 16.4% for rhIL-11 7.5 microg/kg, N.S.).

CONCLUSIONS:

Weekly subcutaneous injection with rhIL-11 15 microg/kg is safe and effective in inducing remission in a subset of patients with active Crohn's disease.

• Authors: B E Sands, B D Winston, B Salzberg, M Safdi, C Barish, L Wruble, R Wilkins, M Shapiro, U S Schwertschlag, RHIL-11 Crohn's Study group
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 16 Issue 3 Pg. 399-406 (Mar 2002) ISSN: 0269-2813 [Print] England
• PMID: 11876692 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Interleukin-11
• Placebos

Topics

• Adolescent
• Adult
• Crohn Disease (drug therapy)
• Edema (chemically induced)
• Female
• Headache (chemically induced)
• Humans
• Interleukin-11 (administration & dosage, adverse effects, therapeutic use)
• Male
• Middle Aged
• Pilot Projects
• Placebos
• Quality of Life
• Treatment Outcome